K-number	K242248
Device name	Introducer Sheath Kits
Applicant	Beijing Demax Medical Technology Co.,Ltd
Product code	DYB
Device class	Class II
Decision date	Aug 22, 2024
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Introducer Sheath Kits

Everything you need for a 510(k) submission. Nothing you don't.